dAVF-PHIL Registry
Research type
Research Study
Full title
PHIL evaluation in the endovascular treatment of intracranial dural AVF
IRAS ID
234734
Contact name
Saleh LAMIN
Contact email
Sponsor organisation
Microvention Europe
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This is an European multi-center observational study. Treatments and follow-up visits will be done as per standard of care. There are no additional procedures or tests.\nThe objective of this study is to evaluate the efficacy and safety of the PHIL® device in the treatment of intracranial dural ArterioVenous Fistula (dAVF). The PHIL® device, a non-adhesive liquid embolic agent, has been CE marked since July 2014. It is intended for use in the embolization of lesions in the peripheral and neurovasculature, including arteriovenous malformations and hypervascular tumors.\nAll patients with an intracranial dAVF that has not been previously treated and will be treated by embolization with PHIL® are eligible for this study. A maximum of 60 patients will be enrolled in this study in 16 European Institutions. \nThe expected approximate study duration is 24 months. \nAs this is an observational study with no additional procedures to standard of care, only patients medical data will be collected.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0109
Date of REC Opinion
16 May 2018
REC opinion
Further Information Favourable Opinion